LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00526305
First received: September 5, 2007
Last updated: January 3, 2010
Last verified: January 2010
  Purpose

Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Vincristine
Drug: Daunorubicin
Drug: Prednisone
Drug: L-Asparaginase
Drug: Mitoxantrone
Drug: Cytosine Arabinoside
Drug: Hydrocortisone
Drug: Mercaptopurine
Drug: Cyclophosphamide
Drug: Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2000
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vincristine
    1,5 mg/m2 i.v., days 1 and 8
    Drug: Daunorubicin
    60 mg/m2, i.v., days 1 and 8
    Drug: Prednisone
    60 mg/m2 day, i.v. or oral, days 1 to 14
    Drug: L-Asparaginase
    10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
    Drug: Mitoxantrone
    12 mg/m2 i.v days 15, 16 and 17
    Drug: Cytosine Arabinoside
    1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
    Drug: Hydrocortisone
    10 mg ,15 mg or 20 mg depending of age
    Drug: Mercaptopurine
    50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
    Drug: Cyclophosphamide
    600 mg/m2 day, i.v., days 1 to 15 in consolidation
    Drug: Dexamethasone
    10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21
Detailed Description:

Remission Induction:

  • Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
  • Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
  • Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
  • L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13

Results:

1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks

2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C

Intrathecal chemotherapy:

Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT 1

Start in two weeks after last dose of induction chemotherapy:

  • Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
  • Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
  • VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
  • ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
  • Intrathecal treatment, days 28 and 56.

6.4. CONSOLIDATION TREATMENT 2

Start in a week after last dose of mercaptopurine of previous cycle

  • Dexamethasone (DXM):
  • 10 mg/m2 day, p.o. or i.v. days 1-14
  • 5 mg/m2 day, p.o. or i.v., days 15-21
  • Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
  • Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
  • CFM 600 mg/m2 day, i.v., days 1 and 15
  • L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
  • Intrathecal treatment days 1 and 15.

TRANSPLANTATION

Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.

Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1

Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ALL BCR/ABL+ patients Age < 65 years No previous treatment

Exclusion Criteria:

  1. Other LLA variability
  2. Previous history of coronary valvular, hypertensive cardiopathy illness
  3. Chronic hepatic illness
  4. Chronic respiratory insufficiency
  5. Renal insufficiency not caused by LLA
  6. Severe neurological problems not caused by LLA
  7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526305

  Show 50 Study Locations
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00526305     History of Changes
Other Study ID Numbers: LAL-Ph-2000
Study First Received: September 5, 2007
Last Updated: January 3, 2010
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia
Chromosome Philadelphia positive

Additional relevant MeSH terms:
Abnormal Karyotype
Leukemia
Leukemia, Lymphoid
Philadelphia Chromosome
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Chromosome Aberrations
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Hydrocortisone
Mitoxantrone
Alkylating Agents
Analgesics
Anti-Infective Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 30, 2014